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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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30 June 2019 |
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Main ID: |
EUCTR2012-001369-34-GB |
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Date of registration:
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15/06/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Proof of biological activity of SAR100842 in Systemic Sclerosis
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Scientific title:
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Double-blind, randomized, 8-week placebo-controlled and 16-week open label extension study investigating the Safety, Pharmacokinetics and Pharmacodynamics of SAR100842 Given Orally to Patients with Diffuse Cutaneous Systemic Sclerosis |
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Date of first enrolment:
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26/10/2012 |
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Target sample size:
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30 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001369-34 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Canada
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Germany
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Italy
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Switzerland
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United Kingdom
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United States
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Contacts
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Name:
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Medical Information
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Address:
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One Onslow Street
GU1 4YS
Guildford
United Kingdom |
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Telephone:
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00441483505515 |
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Email:
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uk-medicalinformation@sanofi.com |
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Affiliation:
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Sanofi-aventis recherche & développement |
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Name:
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Medical Information
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Address:
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One Onslow Street
GU1 4YS
Guildford
United Kingdom |
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Telephone:
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00441483505515 |
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Email:
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uk-medicalinformation@sanofi.com |
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Affiliation:
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Sanofi-aventis recherche & développement |
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Key inclusion & exclusion criteria
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Inclusion criteria:
1.Patients who meet the American College of Rheumatology (ACR) criteria for systemic sclerosis with diffuse cutaneous involvement and <36 months since the onset of the first systemic sclerosis manifestation other than Raynaud's phenomenon and have a Modified Rodnan Skin Score (mRSS) = 15 and an area of definite involvement of the dorsal forearm that is considered amenable to repeated 4mm skin biopsies.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Patients with high dose or unstable low dose immunosuppressive drugs, cytotoxic, anti-fibrotic or glucocorticoids drugs at least 4 weeks prior to screening
2.Serum creatinine > 2.0 mg/dL
3. Gastrointestinal involvement preventing oral administration of study drug
4. Severe cardiac and/or pulmonary disease
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
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Systemic Sclerosis
MedDRA version: 15.1
Level: PT
Classification code 10042953
Term: Systemic sclerosis
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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Intervention(s)
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Product Code: SAR100842
Pharmaceutical Form: Tablet
CAS Number: 1195941-38-8
Current Sponsor code: SAR100842
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: SAR100842
Pharmaceutical Form: Tablet
CAS Number: 1195941-38-8
Current Sponsor code: SAR100842
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): Safety and tolerability during the 8 week treatment period (Number of patients reporting adverse events)
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Secondary Objective: To evaluate the pharmacodynamic effect of SAR100842 in patients with systemic sclerosis as measured by disease related biomarkers and
Lysophoshatidic acid (LPA) receptor signaling markers in blood and skin
To explore the effect of SAR100842 on skin thickness in patients with systemic sclerosis as measured by the Modified Rodnan Skin score (mRSS)
To explore the effect of SAR100842 on quality of life as measured by the Scleroderma Modified Health Assessment Questionnaire (SHAQ)
To document the long term safety and tolerability of SAR100842
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Main Objective: To evaluate safety and tolerability of 8-week oral administration of SAR100842 in patients with diffuse, cutaneous systemic sclerosis.
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Timepoint(s) of evaluation of this end point: Up to 8 weeks
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Secondary Outcome(s)
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Secondary end point(s): Pharmacodynamic changes from baseline to End of Treatment Visit in biomarkers obtained from blood and skin
Change from baseline to End of Treatment Visit in skin severity score (mRSS) and in Scleroderma health assessment questionnaire (SHAQ)
Safety and tolerability of SAR100842
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Timepoint(s) of evaluation of this end point: Pharmacodynamic changes from baseline to End of Treatment Visit in biomarkers obtained from blood and skin - Time Frame: at Day 1 and 8 weeks
Change from baseline to End of Treatment Visit in skin severity score (mRSS) and in Scleroderma health assessment questionnaire (SHAQ) - Time Frame: at Day 1 and 8 weeks
Safey and tolerability of SAR100842 - Time Frame: up to 24 weeks
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Source(s) of Monetary Support
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Sanofi-aventis recherche & développement
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Ethics review
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Status: Approved
Approval date:
Contact:
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